BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1435522 · Received July 31, 2009

    Report

    Report Number
    2021710-2009-00027
    Event Type
    Other
    Date Received
    July 31, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 30, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). (B) (4): BASED ON THE EVAL PERFORMED BY THE USER FACILITY, CARDINAL HEALTH HAS DETERMINED THAT THIS EVENT WAS CAUSED BY A USER ERROR AND LACK OF PREVENTATIVE MAINTENANCE. THIS EVENT COULD HAVE BEEN PREVENTED IF THE USER FACILITY WOULD HAVE CHANGED THE 9V BATTERY AS RECOMMENDED IN THE OPERATORS MANUAL.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. ON (B) (6) 2009: "[NAME REMOVED] CALLED AND UNIT DOES NOT ALARM POWER FAILURE WHEN MAIN AC POWER IS LOST, IT ALARMS WITH ANY OTHER ALARM CONDITION BUT THIS ONE. EXPLAINED THE ALARM BOARD NEEDS TO BE REPLACED AND THAT WE SHOW UNIT IS UNDER CONTRACT. [NAME REMOVED] STATES EVEN THOUGH UNIT IS UNDER CONTRACT, HE CANNOT HAVE PART SENT TO HIM UNTIL PURCHASING CALLS IN AND ASKS FOR IT. GAVE (B) (4) AND WILL WAIT FOR PURCHASING TO CALL TO PLACE ORDER FOR ALARM BOARD UNDER CONTRACT. NO PT INVOLVEMENT." ON (B) (6) 2009: "CALLED [NAME REMOVED] AND HE HAD RERAN THE ALARM FUNCTION TEST IN THE 4K PM AND DETERMINED THAT THE 9V BATTERY VOLTAGE WAS LOW AND WHEN HE CHANGED OUT THE BATTERY HE RESOLVED THE PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 7C3LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA